US-guided SAPB for Rib Fractures in the ED

Sponsor

Andrew A Herring (Other)

Overall Status

Unknown status

CT.gov ID

NCT03619785

Collaborator

Oregon Health and Science University (Other), University of California, Los Angeles (Other)

Enrollment

Location

Arms

9.8

Anticipated Duration (Months)

7.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this randomized controlled study is to determine whether the serratus anterior plane block reduces pain more than the usual treatment for rib fractures in the same amount of time.

Condition or Disease	Intervention/Treatment	Phase
Rib Fractures Rib Fracture Multiple	Drug: Bupivacaine Drug: Fentanyl, morphine, hydromorphone, hydrocodone, acetaminophen, ketorolac, gabapentin, ketamine, ibuprofen	Phase 4

Detailed Description

Patients with unilateral rib fractures in the Highland Hospital Emergency Department who agree to participate will be randomized 1:1 to either the control group or the experimental group. Those in the control group will receive the usual oral and/or IV pain medication as needed. The experimental group will receive an ultrasound-guided serratus anterior plane block. Numerical pain rating scale scores at rest and when taking a deep breath will be recorded pre-intervention and at times 0, 20, 40, and 60. At time 60, patients who received the SAPB will receive sensory testing. Patients will be offered additional pain medication as needed at times 20, 40, and 60.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Ultrasound-guided (US) Serratus Anterior Plane Block (SAPB) for Acute Rib Fractures in the Emergency Department (ED)

Actual Study Start Date :

Nov 6, 2018

Anticipated Primary Completion Date :

Aug 31, 2019

Anticipated Study Completion Date :

Aug 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental (SAPB) Patients randomized to the experimental arm receive an ultrasound-guided serratus anterior plane block for their rib fracture pain.	Drug: Bupivacaine Patient will be positioned supine or in the lateral decubitus position on the side contralateral to the fracture(s). A 3.5 in 20-gauge needle, extension tubing, and a 30 mL syringe loaded with 0.25% bupivacaine and 3 mL of 1% lidocaine loaded in a 5 mL syringe with a 27-gauge needle will be prepared. The ribs, teres minor, latissimus dorsi, and serratus anterior will be identified with bedside US and the site of entry marked along the lateral aspect of the 4th-5th rib. The skin will be sterilized and lidocaine placed at the site of entry. The needle will be introduced at a steep angle and advanced in-plane, under US-guidance, to the plane superficial to the serratus anterior muscle. A test dose of normal saline will confirm proper needle tip placement with opening of the intramuscular layer. Injection with aliquots of 3-5 mL after negative aspiration will continue until 30mL of 0.25% bupivacaine are administered.
Active Comparator: Control Patients randomized to the control arm receive usual pain control treatment in the emergency department.	Drug: Fentanyl, morphine, hydromorphone, hydrocodone, acetaminophen, ketorolac, gabapentin, ketamine, ibuprofen Oral or IV pain medication as needed.

Arm

Intervention/Treatment

Experimental: Experimental (SAPB)

Patients randomized to the experimental arm receive an ultrasound-guided serratus anterior plane block for their rib fracture pain.

Drug: Bupivacaine

Patient will be positioned supine or in the lateral decubitus position on the side contralateral to the fracture(s). A 3.5 in 20-gauge needle, extension tubing, and a 30 mL syringe loaded with 0.25% bupivacaine and 3 mL of 1% lidocaine loaded in a 5 mL syringe with a 27-gauge needle will be prepared. The ribs, teres minor, latissimus dorsi, and serratus anterior will be identified with bedside US and the site of entry marked along the lateral aspect of the 4th-5th rib. The skin will be sterilized and lidocaine placed at the site of entry. The needle will be introduced at a steep angle and advanced in-plane, under US-guidance, to the plane superficial to the serratus anterior muscle. A test dose of normal saline will confirm proper needle tip placement with opening of the intramuscular layer. Injection with aliquots of 3-5 mL after negative aspiration will continue until 30mL of 0.25% bupivacaine are administered.

Active Comparator: Control

Patients randomized to the control arm receive usual pain control treatment in the emergency department.

Drug: Fentanyl, morphine, hydromorphone, hydrocodone, acetaminophen, ketorolac, gabapentin, ketamine, ibuprofen

Oral or IV pain medication as needed.

Outcome Measures

Primary Outcome Measures

Change in Numeric Pain Rating Scale score between time 0 and time 60 when comparing block and control groups [60 minutes]
Change in Numeric Pain Rating Scale scores between time 0 and time 60 between block and control groups: Numeric Pain Rating Scale score at 0 minutes minus Numeric Pain Rating Scale score at 60 minutes, where a score of 0 is no pain and 10 is the worst pain the patient can imagine.

Secondary Outcome Measures

Change in Numeric Pain Rating Scale score at rest versus when taking a deep breath when comparing block and control groups [20, 40, 60 minutes]
Change in Numeric Pain Rating Scale score for resting chest pain and dynamic chest pain at 20, 40, and 60 minutes between block and control groups, where a score of 0 is no pain and 10 is the worst pain the patient can imagine.
Difference in total morphine equivalents [1, 4, 12, and 24 hours]
Difference in total parenteral morphine equivalents received during study period (0 minutes to 60 minutes) and at 4, 12, and 24 hours (unless discharged from the hospital prior to 24 hours) in the block and control groups.
Successful analgesia for block group [20, 40, 60 minutes]
Successful analgesia at 20, 40 and 60 minutes: Proportion of patients not receiving morphine dosing.
Non-opioid medications given (yes/no) [20, 40, 60 minutes]
NSAID, APAP, Gabapentin administered in block versus control groups.
Adverse events [60 minutes]
Proportion of patients with new onset of seizure, arrhythmias, hyper or hypotension (SBP<90 or >180), hypoxia, nausea, lightheadedness, vomiting.
Sensory testing [60 minutes]
Sensory testing to cold stimulus (alcohol swab) in the block group along the lateral sternal, anterior axillary, and posterior axillary lines at the levels of T2-T10 using a 3-point scale: 0 (unchanged), 1 (reduced), or 2 (no sensation).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Males and females 18 years and older, capable of providing informed consent indicating awareness of the investigational nature of the study, in keeping with institutional policy.
Written informed consent must be obtained from each patient prior to entering the study.
Patients with moderate to severe pain (NRS 4 to 10) as a result of one or more rib fractures occurring at levels T2-T8, measured on a self-reported NRS.

Exclusion Criteria:

Patient refusal
Patients with significant pain from other injuries (as determined at the discretion of the treating physician)
Patients deemed critically ill by provider
Patients with decompensated psychiatric disorders
Pregnant patients (positive urine or serum B-HCG)
History of heart block or bradycardia
History of uncontrolled seizures
Patients allergic to lidocaine, bupivacaine, ropivacaine, or morphine
Patients with bilateral rib fractures

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alameda Health System - Highland Hospital	Oakland	California	United States	94602

Sponsors and Collaborators

Andrew A Herring
Oregon Health and Science University
University of California, Los Angeles

Investigators

Principal Investigator: Andrew Herring, MD, Alameda Health System - Highland Hospital
Principal Investigator: Josh Luftig, PA, Alameda Health System - Highland Hospital
Principal Investigator: Eben Clattenburg, MD, Alameda Health System - Highland Hospital
Principal Investigator: Daniel Mantuani, MD, MPH, Alameda Health System - Highland Hospital
Principal Investigator: Arun Nagdev, MD, Alameda Health System - Highland Hospital